Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain (MET-LBP)

March 21, 2022 updated by: Hager Nazieh Mohamed Hekal, Cairo University
to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Low back pain (LBP) affects almost everyone at least once per life. Hence,it has been considered one of the most common musculoskeletal problems.The Pilates Method starts by strengthening the core, which is achieved by coordinating breathing with movement. Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific LBP so this trial will be conducted to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: hager na hekal, PHD student
  • Phone Number: 00201016549132
  • Email: hager_in@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Seventyeight Subjects will be selected from both genders, with age above 18 years.
  • Normal body mass index (BMI) will be included.
  • Participants diagnosed with chronic nonspecific LBP.

Exclusion Criteria:

  • The participants will be excluded if they had one of the following criteria:
  • Patient with previous back surgery, lumbar disc herniation, spinal deformities.
  • Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
  • History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
  • Pregnant women and Osteoprosis.
  • Leg length discrepancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: pilate group
will receive pilate exercise(1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist) and standard treatment (stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions(3 sessions/week) over a period of four weeks.
Other: pilate mat exercise will be performed
pilate group:1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist plus standard treatment(stretch hamstring -stretch lower back - strength abdominal muscles - electrical heat pad)
Experimental: MET
will receiveMET treatment for hamstring and erector spinae and standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions (3 sessions/week)over a period of four weeks.
Other: MET
Will receive MET for hamstring and erectorspinae plus standard treatment
Active Comparator: control group
will receive standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) only for 12 sessions (3 sessions/week) over a period of four weeks.
Other: control group receive standard treatment
electrical heat pad - stretch hamstring - stretch lower back muscles - stregth abdominal muscles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: up to 4 weeks for each group
using visual analogue scale.each patient willbe instructed to rate the current level of pain by placing (X) sign across the horizontal VAS line. The distance in millimeters from the lower limit was measured using a ruler. VAS will be assessed before and after the treatment program.as 1:2 mild , 3:6moderate and 7:10 sever pain.
up to 4 weeks for each group
functional disability
Time Frame: up to 4 weeks for each group
using ronald morris questioneer.The RMDQ is scored by adding up the number of items the patient has ticked. Scores can vary between 0-24. Greater levels of disability are reflected by higher scores
up to 4 weeks for each group
ROM
Time Frame: up to 4 weeks for each group

using BROMII.Use the two universal inclinometers to make flexion/extension measurements. Measurements with the universal inclinometer need to be with the patient in an upright position.

  1. Palpate and mark S1 and T12. Mark on bare skin when possible. This avoids the marks moving with the patient's clothing (Fig.2)
  2. Center the two inclinometers over the palpation marks and zero with your finger by spinning the dial (zero would then be at the bottom of the inclinometer).
  3. Have the patient flex forward as far as possible (Fig. 3). Note the reading on each inclinometer.
  4. The reading on the upper inclinometer is total lumbar flexion. The reading on the lower inclinometer is sacral flexion. The difference between the reading at S1 and T12 is true lumbar flexion.
  5. Repeat flexion protocol for extension having the patient extend back for full extension instead of flexing forward
up to 4 weeks for each group
flexibility
Time Frame: upto 4 weeks for each group
using V sit and reach test.The test is done twice with a short break in between . Scoring: Zero point is at the level of feet. (We note negative values towards our body and positive values outward from our body.) The best trial is recorded in centimeters by best score
upto 4 weeks for each group

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: hager hekal, PHD student, Faculty of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/002135

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings